“Our results confirm that, in most cases, statin therapy is unlikely to cause muscle pain in a person taking statin therapy,” said the study, led by authors from Oxford Population Health and the Medical Research Council Population Health. Research Unit at the University of Oxford. “This finding is especially true if the treatment is well tolerated for a year or more before symptoms appear.”
The authors conducted a meta-analysis of 19 randomized double-blind studies of statin treatments versus placebos. All studies had more than 1,000 participants and a follow-up of at least two years. They also looked at four double-blind studies of more and less intensive statin regimens.
Study author Colin Baigent, a professor of epidemiology at the University of Oxford, said there have been many non-randomized studies not involving any form of placebo or random assignment to a statin, which have provided “really pretty extreme” estimates of how much muscle pain cause statins.
“This has kept patients from starting statins, or they’ve stopped treatment when they get muscle pain, because they just look in the paper and they see that statins cause a lot of muscle pain and so they stop,” Baigent said during a study. Science Media Center briefing. “We were really trying to address that problem.”
The new study says that “even during the first year of moderate-intensity statin treatment, this is likely to be the cause in only about one in 15 patients reporting muscle symptoms, rising to about one in 10 in those on a more intensive regimen.”
“In other words, the statin does not cause muscle symptoms in more than 90% of individuals who report such symptoms.”
The authors found that statin therapy caused a 7% relative increase in muscle pain or weakness in the first year, but there was no significant increase after that. The increased risk was already present in the first three months after treatment was awarded.
There were reports of at least one episode of muscle pain or weakness in 27.1% of patients who received a statin compared with 26.6% of those who received placebo during a median follow-up of 4.3 years.
In the studies reviewed by the authors, they say that statin therapy caused about 11 additional muscle pain reports per 1,000 patients during the first year of use.
“What we conclude is that there are two things we need to do as a profession, as a society,” Baigent said in the briefing. “The first is that we need to better treat patients who report muscle pain when they are on a statin, because patients tend to eventually stop taking the statin and that has an adverse effect on their long-term health. And the second that we What we need to do is look at the information available to patients in package inserts.”
He noted that if people were better informed about the real risks of muscle pain, they might be able to continue on statin therapy for longer.
The study has some limitations, including significant heterogeneity in the methods used for muscle symptoms, some data on side effects are not available, and most studies do not exclude participants who can now be categorized as statin intolerant.
In a commentary published alongside the study, Dr. Maciej Banach, a cardiologist at the Medical University of Lodz and the Polish Mother’s Memorial Hospital Research Institute in Poland, said the possible side effects of statins should not be a consideration when starting treatment.
“It should be strongly emphasized that the small risk of muscle symptoms is insignificant compared to the well-proven cardiovascular benefits of statins,” he wrote.
Last week, the US Preventive Services Task Force announced its latest guidelines on using statins to prevent a first-time heart attack or stroke.
The guidelines are more conservative than those of other groups, such as the American College of Cardiology. They recommend statins in adults ages 40 to 75 who have at least one risk factor for cardiovascular disease and a 10% or high risk of heart attack in the next 10 years.